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Product Name: Fluticasone Propionate
Chemical Formula: C25H31F3O5S
Synonyms: Flixonase, Flovent, Flonase
CAS Number: 80474-14-2
Recommended Use: Corticosteroid for treatment of respiratory allergic conditions
Manufacturer: Major pharmaceutical manufacturers distribute under prescription
Emergency Telephone: Refer to regional poison control center for accidental exposures
Classification: Not classified as hazardous under GHS for general handling. Can cause moderate irritation to eyes, skin, and respiratory tract. Hazard concerns grow with dust formation and accidental chronic inhalation or ingestion.
Signal Word: Caution
Hazard Statements: Risk of respiratory effects in sensitized individuals. Prolonged contact increases chance of local skin reactions. May trigger symptoms similar to systemic corticosteroid exposure.
Pictogram: None mandated for solid compound at small scale condensations; treat as dust hazard in production settings.
Chemical Name: Fluticasone Propionate
CAS No.: 80474-14-2
Concentration: 100% pure active pharmaceutical ingredient when supplied in bulk
Impurities: Specifications allow minimal levels below regulatory thresholds
Inhalation: Move exposed person to fresh air immediately. Watch for ongoing respiratory distress. Medical attention required for persistent symptoms.
Skin Contact: Wash exposed area thoroughly with water and mild soap. Remove contaminated clothing. If irritation persists, seek medical guidance.
Eye Contact: Flush eyes with cool running water for at least 15 minutes. Do not let victim rub eyes. Consult an ophthalmologist if discomfort remains.
Ingestion: Rinse mouth with water. Never give anything by mouth if victim loses consciousness. Call medical personnel for advice if appreciable amounts are swallowed.
Suitable Extinguishing Media: Carbon dioxide, foam, dry chemical powder. Water spray can control nearby fires but avoid direct high-volume streams.
Specific Hazards: Combustion may create carbon oxides, sulfur oxides, hydrogen fluoride, and other toxic gases. Dust may form explosive mixture in air under certain conditions.
Protective Equipment: Firefighters should wear full protective clothing including breathing apparatus.
Personal Precautions: Restrict access to area. Wear suitable respiratory protection and gloves. Avoid raising dust or aerosol.
Environmental Precautions: Prevent entry of large quantities into drains, surface water, or soil.
Method for Clean-Up: Use damp cloth or HEPA-filter vacuum for spill collection. Dispose according to local regulations for pharmaceutical waste.
Handling: Operate in well-ventilated environment. Prevent dust formation. Use standard pharmaceutical GMP hygiene standards. Minimize contact with skin, eyes, and clothing.
Storage: Keep tightly closed in original packaging. Store in dry, cool, well-ventilated area. Shield from sunlight and moisture. Keep away from incompatible materials such as strong acids, bases, oxidizers.
Engineering Controls: Use local exhaust ventilation where dust may form. Closed processing recommended for bulk handling.
Personal Protective Equipment: Gloves, lab coat, dust mask (N95 or higher for powder handling), and goggles. Respiratory protection if adequate ventilation is unavailable.
Occupational Exposure Limits: No official regulatory exposure limit set but internal company limits often used for pharmaceutical production employees.
Appearance: White to off-white crystalline powder
Odor: Odorless or faint chemical scent
Melting Point: 273°C
Boiling Point: Not applicable (decomposes)
Solubility: Practically insoluble in water, soluble in dimethyl sulfoxide and acetone
pH: Not applicable (solid compound)
Vapor Pressure: Negligible at standard temperature
Flash Point: Data not available, not considered flammable under normal conditions
Chemical Stability: Stable under recommended storage and handling conditions. Excess exposure to light, moisture, acid, or base can accelerate degradation.
Possibility of Hazardous Reactions: Does not polymerize; violent reactions can occur with strong oxidizers.
Decomposition Products: Yields toxic gases including carbon monoxide, carbon dioxide, hydrogen fluoride, sulfur oxides during combustion.
Acute Toxicity: Low acute toxicity in expected pharmaceutical doses but not intended for ingestion in bulk. Animal studies show no significant risk of acute toxicity at therapeutic levels.
Chronic Effects: Prolonged, unreasonable exposure can suppress adrenal function, decrease immune response, or upset metabolic regulation similar to systemic corticosteroids.
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Symptoms: Irritation to eyes and mucous membranes, dryness, itching, rare allergic skin reactions. Systemic effects at high accidental doses.
Carcinogenicity/Mutagenicity: Animal studies did not indicate a carcinogenic risk at expected exposure levels in medical use.
Ecotoxicity: No specific data for environmental toxicity at low concentrations typical for pharmaceuticals in wastewater. High doses may impact aquatic species. Data indicate low bioaccumulation potential.
Persistence: Chemical structure demonstrates persistence in the environment but expected to be degraded slowly by biotic and abiotic processes.
Mobility: Immobile in soil due to low water solubility. Not expected to migrate significantly from spill site.
Waste Treatment: Dispose of via approved pharmaceutical waste contractors. Incineration is recommended for all bulk waste.
Packaging: All contaminated materials, containers, and residues require disposal according to regional regulations governing medical substances.
Precautions: Do not dispose into sewage system or natural waterways. Avoid open dumping where uncontrolled release can occur.
UN Number: Not regulated as hazardous substance for transport under ADR/RID, IMDG, IATA standards.
Proper Shipping Name: Fluticasone Propionate, not classified as dangerous good
Packing Group: No special classification
Transport Precautions: Protect from excessive heat, moisture, and physical shock. Store in original packaging during transit.
Labelling Requirement: Supply pharmaceutical labeling for regulated products. Bulk containers may follow workplace hazard communication rules.
Regulatory Status: Prescription use only in most jurisdictions. Covered under Controlled Substances Act in certain countries. Manufacturing follows GMP standards.
OSHA/WHMIS: Not specifically listed as hazardous. Apply internal industrial hygiene procedures for active pharmaceutical ingredients.
Other Regulatory Data: The product meets European Medicines Agency, US FDA and local standards for manufacturing and handling.
